NCT01823445

Brief Summary

The purpose of this study is to demonstrate whether decay causing bacteria are reduced when adhesive xylitol disks are used intraorally three times a day for two weeks in adults with dry mouth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

March 27, 2013

Last Update Submit

December 1, 2013

Conditions

Mutans StreptococciXerostomia

Keywords

XylitolDental caries

Outcome Measures

Primary Outcomes (2)

  • Mutans streptococci levels

    Change in mutans streptococci levels from Baseline to one week.

    One week

  • Mutans streptococci levels

    Change in mutans streptococci levels from Baseline to two weeks.

    Two weeks

Secondary Outcomes (2)

  • GRIX measure of xerostomia

    One week

  • GRIX measure of xerostomia

    Two weeks

Study Arms (1)

Xylitol disk

EXPERIMENTAL

Daily use of 8 disks containing 0.5 grams xylitol each for two weeks. The disks adhere to gum tissue with a food grade adhesive backing and slowly dissolve. The disks are applied one on each side of the mouth in the morning after breakfast, again at midday, and four are applied, two on each side, at bedtime.

Other: Xylitol disk

Interventions

Xylitol diskOTHER
Also known as: XyliMelts
Xylitol disk

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 21 years old or older
  • Daily use of at least 2 prescription medications known to cause dry mouth
  • Current report of dry mouth

You may not qualify if:

  • Antibiotic use in the last month
  • Topical oral antimicrobial (e.g. Chlorhexidine rinse) use in the last month
  • Change in medication or dose within the last month
  • Use of mouthwash within the last week
  • Use of lozenges or chewing gum with 500 mg or more of xylitol on a habitual basis
  • History of gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, School of Dentistry, Regional Clinical Dental Research Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

XerostomiaDental Caries

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Study Officials

  • Peter Milgrom, DDS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

US(1)